Trigemina, the Moraga, California-based developer of nasally delivered analgesic drug formulations, is looking to raise USD 22m in its Series B round this year, President and CEO Charles Yeomans said.
The company has not yet engaged advisors, but will most likely retain a boutique advisory firm, he noted. It is receptive to approaches from advisors to this end.
Proceeds would go towards funding its Phase IIb trial for TI-001, Trigemina’s proprietary nasal formulation that includes oxytocin, for the treatment of migraine headaches, through to development. The trial will start in September, so there is a certain time pressure to raise the funds, he added. Trigemina has raised a total of USD 18m to date, Yeomans noted.
It will conduct the Phase IIb trial primarily in the US. The trial may also include the UK and Canada, and possibly Japan if it is able to identify a Japanese partner, he said.
On the CRO front, Trigemina is narrowing down the number of possible candidates through a RFP process; all of the potential CRO providers have operations in the US and Japan, he continued.
The Phase IIb will be a dose-ranging study with 400 patients, he noted. The patients will be given three different doses and a placebo. The trial is expected to be completed in early 2018. Trigemina also hopes to include Japanese subjects, he said.
To this end the company has held some discussions with Japanese pharma, Yeomans continued. The partner could enroll and manage the site or sites involved in Japan – essentially manage the entire process from the Japanese perspective, he added.
The CMC (chemistry and manufacturing controls) is under way and a manufacturer has been selected, he said. An investigational new drug (IND) filing is projected for the second quarter and the FDA is onboard in general terms with the clinical plan, he noted, adding that it had been 505(b)(2) qualified.
It has also held discussions with Dr Fumihiko Sakai, Professor of Saitama Medical University and Director of the Saitama International Headache Center, Japan’s first specialized headache clinic, who believes Trigemina’s product would be beneficial for the Japanese population, he said. A high percentage of his patients are children and adolescents with chronic and high frequency migraine, he added.
Sakai also serves as a member of the scientific advisory board at Trigemina.
Separately, the company is expecting to raise USD 2m in the form of a convertible bridge note in the next 60 days, he noted.
The current market for migraine drugs is not large, about USD 1bn in the G7 at present, but is expected to be worth USD 8bn-USD 10bn within a few years, he said. Globally, about 18% of women and 6% of men suffer from migraines, Yeomans said. About 40% of migraine patients, or almost 5% of the total population, experience headaches five or more days per month. Patients who are most affected are known as chronic migraineurs; those who suffer from headaches 15 or more days a month, and they constitute about 1.5%-2% of the total population, he continued.
Migraine drugs fall into two basic categories: acute and prophylactic treatments. The greater need in the view of neurologists is for better prophylactic drugs for migraine patients who experience a high frequency of migraine headaches, he said. Trigemina’s drug falls into the prophylactic category.
The current migraine prophylaxis products in the market are generally regarded as producing inadequate reduction in the frequency with which patients have headaches, generally reducing the incidence of migraine headache days by 25%-30%. In the US, Botox has been approved to prevent chronic migraine, he continued.
Trigemina’s recently completed Phase II trial began last fall in Chile, Australia, and New Zealand, he said. A total of 218 patients were enrolled and the safety profile and efficacy of TI-001 was deemed positive, he noted. Two serious adverse events (SAEs) were recorded, but neither of which were related to the drug, he added. One was a UTI in the patient while the other suffered extremely bad migraines and had to be sent to the hospital, he continued.
Investors in the company include Chilean venture capital firm Aurus Bios and high net worth individuals, according to a previous report from this news service. In June 2013, Trigemina announced the completion of its USD 4.5m Series A-1 financing, led by Aurus.
Trigemina continues to work with contract development and manufacturing organization (CDMO) DPT Labs and contract research organization (CRO) AfaSci, as reported.
by Mai Mizuta and Yurika Masuda in Tokyo
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